Repaglinide
These highlights do not include all the information needed to use REPAGLINIDE TABLETS safely and effectively. See full prescribing information for REPAGLINIDE TABLETS. REPAGLINIDE tablets, for oral use Initial U.S. Approval: 1997
Approved
Approval ID
7a93246c-9323-40c4-b590-a40dcb133c8c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 4, 2023
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Repaglinide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-250
Application NumberANDA207209
Product Classification
M
Marketing Category
C73584
G
Generic Name
Repaglinide
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2023
FDA Product Classification
INGREDIENTS (12)
REPAGLINIDEActive
Quantity: 2 mg in 1 1
Code: 668Z8C33LU
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Repaglinide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-249
Application NumberANDA207209
Product Classification
M
Marketing Category
C73584
G
Generic Name
Repaglinide
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2023
FDA Product Classification
INGREDIENTS (12)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
REPAGLINIDEActive
Quantity: 1 mg in 1 1
Code: 668Z8C33LU
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
Repaglinide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33342-248
Application NumberANDA207209
Product Classification
M
Marketing Category
C73584
G
Generic Name
Repaglinide
Product Specifications
Route of AdministrationORAL
Effective DateApril 4, 2023
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
REPAGLINIDEActive
Quantity: 0.5 mg in 1 1
Code: 668Z8C33LU
Classification: ACTIB
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
MEGLUMINEInactive
Code: 6HG8UB2MUY
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT